RAIDING PAIN CLINICS
December 4, 2007
Published at www.paincare.org
The National Foundation for the Treatment of Pain
The latest media blitz from law enforcement concerns the closing of “pill mills”. Great fanfare accompanies the news releases about clinics being shut down that “hand out hundreds of prescriptions for hydrocodone, Xanax and Soma.” The assertion is that “the streets are awash in these drugs and it’s the result of medically unnecessary prescribing by unprincipled doctors.”
Wait just a second, please.
The fact is that these clinics are supported by thousands of patients who simply cannot afford more extensive or sophisticated medical care. These patients are largely from the blue collar workforce. Because of the often brutally physical nature of their employments and long work histories from an early age, blue collar people are prone to very high incidences of structural damage, traumatic osteoarthritis, rheumatoid arthritis, late complications of injuries, spinal degeneration, and other stress-related somatic disorders.
They are often uninsured or under-insured. If they are workman comp patients they are typically abandoned by their insurers or so hassled by “case managers” that they have given up on trying to get comprehensive care with continuity of care-givers. All they can afford, typically, is the five minutes of attention, for $50 per month, that high volume, low-cost clinics provide.
These clinics must be high volume, in order to maintain fiscal viability. If they see 60 or 100 patients a day, at $50 each, they will gross $3,000 to $5,000 per day. By the standards of any sophisticated medical out-patient facility, this is “chump-change”. Such a clinic will have to employ a receptionist, a doctor, a physician’s assistant (or two), a nurse, a book-keeper and someone to do maintenance. With $3000 a month in rent, and insurance and utilities on top of salaries (plus unemployment security payments) such a clinic might net $20,000 a month, /before/ taxes. This is not high-dollar crime. This is low-income subsistence for a medical facility.
But, clinics like these are easy targets. Because of their necessary patient volume there are often substantial numbers of patients milling around waiting to be seen. Their cars are in the parking lot. The clinics’ names are boldly identified for the public to see. Often the medical personnel are foreign medical graduates, adding another element - racial profiling and prejudice - to their vulnerability to being targeted. The monotonous sameness of the minimal medical care they can afford to provide their blue-collar clientele (hydrocodone, Xanax and Soma) further dooms them to stereotypy. So, low
cost, high-volume clinics for the pain management of the blue-collar workforce easily become “pill mills” in the eyes of the authorities who really could care less about the poor people who frequent them.
The goal is to “get the drugs off the streets”. But what is actually accomplished is to drive all the blue collar patients into the streets, seeking relief from their suffering. Their choices become:
1. Score hydrocodone off the street
2. Score heroin off the street
3. Try to drown their pain with alcohol.
No one can tolerate unrelieved pain. It is simply not possible. So as long as there is a large profit to be made by supplying drugs to people who can’t get them legally, there will be a huge and flourishing black market on the streets. Closing the low cost pain clinics does not make the problem better; it makes it worse. Drug prohibition IS the engine that drives and supports the black market in drugs.
Only a VERY, VERY small percentage of all the people who buy illicit pain medications do so because they suffer an addictive disorder. At least 90 % are actually people in pain who in fact hate to have to use medication at all.
So where can they go after the police shut down their clinics? We all know where they have to go. So, whose side is law-enforcement actually on? We know what side L.E. "wants" to be on. But where does it actually end up? You know the answer.
The solution is to end opiophobia and fantasy-driven public policy. Establish publicly supported clinics so that every person who needs relief from suffering can get the same quality of care as those who have the financial means to see legitimate and skilled doctors. Demythologize medications and substance abuse. Treat the actually small numbers of people who have addictions with proper, effective medical care. Terminate the assignment of law enforcement to policing drugs (they can’t anyway, isn’t that abundantly obvious from fifty years of trying?) Confront the obvious fact that law enforcement, adjudication, prison and parole, are now totally strung out on the drug prohibition laws and need to be brought back to reality. Over half the 1 out of 21 people in America who are currently on federal parole or probation (that incidence was 1 out 51 in 1985) are in that situation because of non-violent, drug-related crimes.
We can no longer afford this historical folly. It is destroying the nation and creating a disaffected, crime-wise, cynical underclass of disenfranchised ex-felons whose numbers will soon inundate what is left of our society (if one includes those on state probation or parole, nearly every sixth person walking down the street is in trouble with the law and can’t vote.)
So wake up America. Time is running out and the dope lords are making billions. (the little “pain clinics” in the strip shopping centers sure aren’t.)
J.S. Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org
AFTERWORD
May 27, 2010
Three years later - and the current news is that we have spent 1 trillion dollars on the "War on Drugs" (almost 20% of our total current federal indebtedness). And the big news is that the push to "close down the pill mils" (Louisiana, Texas and Florida) is now hysterical.) why?
• Illicit drugs are more common, more abused, cheaper and purer than ever. Kids are over-dosing more often or greater combinations of drugs. Abuse of prescriptive medications has increased. Legitimate Pain is less frequently medically treated. Fewer doctors are willing to risk prescribing for pain. Even terminal cancer patients are more often dying in uncontrolled suffering. State Medical Boards have ramped up licensure and disciplinary actions related to opioids more than ever. The DEA budget is higher than ever. The incidence of imprisonment for non-violent, drug-related offenses is at an apogee.
• Unemployment remains double-digit as the current recession continues. The viability of the Gulf of Mexico is at imminent risk from a calamitous oil spill - caused by incompetence, greed and corner-cutting. Big money in the world markets continues to roil as the economic viability of Europe and perhaps the rest of the world hangs on a thin edge. Iran continues to develop its nuclear potential for weaponry. North Korea has just provoked South Korea in the worst incident in 55 years. Iraq continues to be an endless political and military morass exceeded only by Afghanistan. The U.S. Congress is a hopeless political stalemate - in which right-wing extremists threaten to take over the Republican party and accelerate its descent into a Whig-like demise. President Obama is demonized for not having solved the mess he inherited from eight years of Republican follies aided and abetted by lobbyist controlled Democratic congress people - wars, insolvency, illegal immigration, a catastrophically failed War on Drugs and its bizarre public policy hand-maiden, driven by hysteria and irrationality.
• The illegal drug market is now estimated to produce between 500 billion and a trillion dollars a year. There is a full blown war in Mexico over the control of drug money, which killed more people in 2009 than the entire total of U.S. soldiers killed in Iraq, from 2002 to the present. Mexican hit squads have invaded the United States and operate with impunity in every major city.
• The frustrations of the completely failed War on Drugs has created an unacknowledged strategy of turning on the helpless, and those who try to treat them, who are easy targets. Impotent to confront the Narco-tafficantes, and their superbly-funded and equipped armies, the Drug-warriors and their legislative sycophants, think they can conceal their emasculation behind this. And given the mindless gullibility of (to steal a phrase from H.L.Mencken) the "Boobus Americanus", it might just work for a couple more years of brain-dead Prohibition.
Given all this, is there any need to wonder why drugs have become such an integral part of the 21st century experience?
What is desperately needed is rationality, in every arena. What is right, rational and appropriate, must be given priority over what is most profitable. Money doesn't matter when the world has become lifeless and/or moribund.
In Florida, every single person who has had to go to a "pill mill" should join together to march on the legislature and DEMAND public funding of the legitimate care they need and threaten mayhem if the treatment of their pain is turned over to the Black Market.
One million people should march on Congress to demand the immediate repeal of Drug Prohibition and the War on Drugs. ALL the non-violent drug offenders should be immediately released and either pardoned or placed on probation, with the stipulation that if they descend into addiction again they are going into treatment for as many times and as long as it takes, to get their addictive disorders into remission. Hundreds of thousands must march on every state legislature to demand the same. The trillions being exsanguinated on policing, prosecution and incarceration of people with addictions must be redirected toward education, treatment, job-training, and the creation of vital economic development and growth. The billions being shoveled into the pockets of Mexican drug king-pins must be immediately terminated by eliminating their markets. Legalize domestic marijuana production, regulate and tax it (see Holland). Provide heroin at addiction clinics until the addicts can be effectively transitioned into treatment. Use whatever other drugs people want to abuse as inducements into the clinics that will treat them. (Want to sniff cocaine, drop downers, eat your Grandfather's OxyContin smoke a joint and drink Bacardi? Come on down to the clinic, We are eager to meet you and figure out what you really need. Hurry. It's free.)
JSH
Thursday, May 27, 2010
Monday, May 17, 2010
Commentary in British Medical Journal
Cohort study finds nine times increased overdose risk (fatal plus non-fatal) in patients receiving 100 mg/day for 90 days compared with 1–20 mg/day opioids for chronic non-cancer pain, but wide CI and possibility of unmeasured confounders
Joel Simon Hochman1, Joe Pergolizzi
British Medical Journal, Evid Based Nurs 2010;13:55-56 doi:10.1136/ebn1062
+ Author Affiliations
National Foundation for the Treatment of Pain, Houston, Texas, USA
Department of Anesthesiology, Georgetown University School of Medicine, Washington, District of Columbia, USA
Naples Anesthesia and Pain Associates, Naples, Florida, USA
Correspondence to: Joel Simon Hochman
Executive Director, National Foundation for the Treatment of Pain, 1714 White Oak Drive, Houston, TX 770099, USA; jfshmd@gmail.com
Commentary on:
Dunn KM, Saunders KW, Rutter CM, et al
Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152:85–92.
Dunn and colleagues are employed at Group Health Research Institute, the Arthritis Research Campaign National Primary Care Centre and Kaiser Permanent, with affiliations at the University of Washington and the University of California in San Francisco, and with funding from the National Institute of Drug Abuse. From their website (http://www.grouphealthresearch.org/aboutus/aboutghri.html) we note that “Group Health Research Institute (GHRI) is a non-proprietary, public-domain research institution within Group Health, a health care system based in Seattle, Washington. Group Health Cooperative is a consumer-governed, nonprofit health care system that coordinates care and coverage. Based in Seattle, Group Health and its subsidiary health carriers, Group Health Options, Inc. and KPS Health Plans, serve nearly 600,000 residents of Washington State and Idaho. More than 70% of members receive care in Group Health-owned medical facilities.”
This study addressed the increasing frequency of long-term opioid treatment for chronic pain and the doubling of hospitalisations for overdose in Washington, DC. The authors noted a study in West Virginia which found that fewer than 44% of people who died of unintentional prescription drug overdose had received opioids from a physician, which suggests that overdose typically resulted from drug diversion. They then explained that “the overdose risk in patients receiving medically prescribed opioids has not been studied.” This is the focus of their research and report.
Their objectives were to estimate the overall overdose rates (non-fatal and fatal) among people receiving long-term opioid therapy for chronic non-cancer pain from medical sources and to compare the risks for opioid overdoses of long-term opioid therapy.
Their study was based on data obtained from the Consortium to Study Opioid Risks and Trends, which was conducted within the Group Health Cooperative. The cohort they studied consisted of 9940 people from the 600 000 insured by Group Health Incorporated who had received opioid therapy for non-cancer pain, followed for a mean of 42 months (range <1 to 119 months). Two-thirds of the cohort had received a diagnosis of back or extremity pain. The mean daily dosage of opioids prescribed was 13.3 mg (morphine equivalents). Among 46% of the cohort, hydrocodone was the most commonly prescribed opioid, and 10% of the cohort had received predominantly long-acting opioids. During the observation period 51.2% were using opioids, 40.1% at the lowest dosage (1 to <20 mg/day of morphine equivalents), 6.7% at 20–49 mg/day, 6% at 50–99 mg/day and 1.8% at ≥100 mg/day.
During the study the authors identified 6 fatal and 74 non-fatal overdoses. Of the 74 non-fatal overdoses, 2 were identified as definitely not opioid overdoses, 17 as probably not and 10 as uncertain. So, a total of 45 non-fatal opioid overdoses were studied. Of the 51 cases studied in total, 40 (78%) were fatal or serious overdoses, and 11 (21.6%) were non-serious overdose events. Accidental excess ingestion of opioids occurred in eight patients, suicide attempts were made by six people, three people had obtained additional opioid from non-medical sources, and drug abuse was noted for four patients. Four patients had overdosed by applying extra fentanyl patches without medical authorisation or by sucking a patch.
The authors concluded that the annual rate of overdose for the total sample was 148 per 100 000 person years, and 116 per 100 000 person years for serious overdose. The rate for patients who had only recently been prescribed opioid therapy was 256 per 100 000 person years. Overdose rates were somewhat higher for patients older than 65 years and among patients with a history of depression and substance abuse. The overall rate of fatal overdose (6 patients of 9940 studied) was 17 per 100 000 person years.
The authors reported that people receiving <20 mg/day of opioids had an annual overdose rate of 160 per 100 000 person years, whereas patients receiving >100 mg/day had a rate of 1791 per 100 000 person years (“a ninefold increase compared to people receiving the lowest dose”). Also, “persons receiving the highest doses were more often men, smokers, had a history of depression treatment and had a history of substance abuse treatment”.
The authors concluded that, “in our study, patients receiving higher doses of medically prescribed opioids for chronic non-cancer pain were at increased risk for overdose relative to patients receiving lower doses.” However, they added, “because few events were observed in the sample, we could not assess overdose risk for specific opioids or risk differences for long-acting versus short-acting opioids.”
Conclusions
The use of statistics sometimes clouds understanding rather than improves it. The simplest conclusion from this study should have been that the rate of fatal overdose is 6/9940 (1 out of every 1656 patients over a 42-month period, or 1 per 5796 patients per year). The non-fatal overdose rate was 45/9940 (1 out of 148 patients over a 42-month period, or 1 out of 516 per year). Calculations of rates per 100 000 person years are not clarifying or particularly useful.
The reported statistical associations between dosage and overdose rates are also not clarifying. Less than 20 mg/day of morphine equivalents is an insignificant dosage for most chronic opioid patients, particularly in the form of hydrocodone. A dosage of >100 mg/day of morphine equivalents is fivefold greater and obviously associated with more profound pain and therefore an increased likelihood of substance abuse, depression and suicide (all of which were reported by the authors).
If one calculates that chronic pain patients take four doses of opioid per day, and that 9940 patients were studied, the annual number of doses of opioid consumed would be 14 512 000. On the basis of this calculation, the rate of fatal overdose would be 1.71 per 14 512 000 doses, or 1.2e−7%; the rate of non-fatal overdose would be 45 per 14 512 000 doses, or 3.1−6%.
Finally, the significance of the statistical association between dosage and overdose rates is questionable. One would ordinarily assume that patients suffering from the greatest pain, and thus requiring the highest dosages of opioid, would also be at much higher risk for depression, suicide and substance abuse. Therefore, any attempt to associate overdose rates and dosage statistically would likely be an artefact of a post hoc error in logic. The causes of an overdose are far more likely to be the extent and duration of pain, depression and suicidality, the extent to which the pain is relieved or naiveté about the use of opioids, rather than the milligram dosage consumed.
Previous Section
Footnotes
Competing interests None.
Joel Simon Hochman1, Joe Pergolizzi
British Medical Journal, Evid Based Nurs 2010;13:55-56 doi:10.1136/ebn1062
+ Author Affiliations
National Foundation for the Treatment of Pain, Houston, Texas, USA
Department of Anesthesiology, Georgetown University School of Medicine, Washington, District of Columbia, USA
Naples Anesthesia and Pain Associates, Naples, Florida, USA
Correspondence to: Joel Simon Hochman
Executive Director, National Foundation for the Treatment of Pain, 1714 White Oak Drive, Houston, TX 770099, USA; jfshmd@gmail.com
Commentary on:
Dunn KM, Saunders KW, Rutter CM, et al
Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152:85–92.
Dunn and colleagues are employed at Group Health Research Institute, the Arthritis Research Campaign National Primary Care Centre and Kaiser Permanent, with affiliations at the University of Washington and the University of California in San Francisco, and with funding from the National Institute of Drug Abuse. From their website (http://www.grouphealthresearch.org/aboutus/aboutghri.html) we note that “Group Health Research Institute (GHRI) is a non-proprietary, public-domain research institution within Group Health, a health care system based in Seattle, Washington. Group Health Cooperative is a consumer-governed, nonprofit health care system that coordinates care and coverage. Based in Seattle, Group Health and its subsidiary health carriers, Group Health Options, Inc. and KPS Health Plans, serve nearly 600,000 residents of Washington State and Idaho. More than 70% of members receive care in Group Health-owned medical facilities.”
This study addressed the increasing frequency of long-term opioid treatment for chronic pain and the doubling of hospitalisations for overdose in Washington, DC. The authors noted a study in West Virginia which found that fewer than 44% of people who died of unintentional prescription drug overdose had received opioids from a physician, which suggests that overdose typically resulted from drug diversion. They then explained that “the overdose risk in patients receiving medically prescribed opioids has not been studied.” This is the focus of their research and report.
Their objectives were to estimate the overall overdose rates (non-fatal and fatal) among people receiving long-term opioid therapy for chronic non-cancer pain from medical sources and to compare the risks for opioid overdoses of long-term opioid therapy.
Their study was based on data obtained from the Consortium to Study Opioid Risks and Trends, which was conducted within the Group Health Cooperative. The cohort they studied consisted of 9940 people from the 600 000 insured by Group Health Incorporated who had received opioid therapy for non-cancer pain, followed for a mean of 42 months (range <1 to 119 months). Two-thirds of the cohort had received a diagnosis of back or extremity pain. The mean daily dosage of opioids prescribed was 13.3 mg (morphine equivalents). Among 46% of the cohort, hydrocodone was the most commonly prescribed opioid, and 10% of the cohort had received predominantly long-acting opioids. During the observation period 51.2% were using opioids, 40.1% at the lowest dosage (1 to <20 mg/day of morphine equivalents), 6.7% at 20–49 mg/day, 6% at 50–99 mg/day and 1.8% at ≥100 mg/day.
During the study the authors identified 6 fatal and 74 non-fatal overdoses. Of the 74 non-fatal overdoses, 2 were identified as definitely not opioid overdoses, 17 as probably not and 10 as uncertain. So, a total of 45 non-fatal opioid overdoses were studied. Of the 51 cases studied in total, 40 (78%) were fatal or serious overdoses, and 11 (21.6%) were non-serious overdose events. Accidental excess ingestion of opioids occurred in eight patients, suicide attempts were made by six people, three people had obtained additional opioid from non-medical sources, and drug abuse was noted for four patients. Four patients had overdosed by applying extra fentanyl patches without medical authorisation or by sucking a patch.
The authors concluded that the annual rate of overdose for the total sample was 148 per 100 000 person years, and 116 per 100 000 person years for serious overdose. The rate for patients who had only recently been prescribed opioid therapy was 256 per 100 000 person years. Overdose rates were somewhat higher for patients older than 65 years and among patients with a history of depression and substance abuse. The overall rate of fatal overdose (6 patients of 9940 studied) was 17 per 100 000 person years.
The authors reported that people receiving <20 mg/day of opioids had an annual overdose rate of 160 per 100 000 person years, whereas patients receiving >100 mg/day had a rate of 1791 per 100 000 person years (“a ninefold increase compared to people receiving the lowest dose”). Also, “persons receiving the highest doses were more often men, smokers, had a history of depression treatment and had a history of substance abuse treatment”.
The authors concluded that, “in our study, patients receiving higher doses of medically prescribed opioids for chronic non-cancer pain were at increased risk for overdose relative to patients receiving lower doses.” However, they added, “because few events were observed in the sample, we could not assess overdose risk for specific opioids or risk differences for long-acting versus short-acting opioids.”
Conclusions
The use of statistics sometimes clouds understanding rather than improves it. The simplest conclusion from this study should have been that the rate of fatal overdose is 6/9940 (1 out of every 1656 patients over a 42-month period, or 1 per 5796 patients per year). The non-fatal overdose rate was 45/9940 (1 out of 148 patients over a 42-month period, or 1 out of 516 per year). Calculations of rates per 100 000 person years are not clarifying or particularly useful.
The reported statistical associations between dosage and overdose rates are also not clarifying. Less than 20 mg/day of morphine equivalents is an insignificant dosage for most chronic opioid patients, particularly in the form of hydrocodone. A dosage of >100 mg/day of morphine equivalents is fivefold greater and obviously associated with more profound pain and therefore an increased likelihood of substance abuse, depression and suicide (all of which were reported by the authors).
If one calculates that chronic pain patients take four doses of opioid per day, and that 9940 patients were studied, the annual number of doses of opioid consumed would be 14 512 000. On the basis of this calculation, the rate of fatal overdose would be 1.71 per 14 512 000 doses, or 1.2e−7%; the rate of non-fatal overdose would be 45 per 14 512 000 doses, or 3.1−6%.
Finally, the significance of the statistical association between dosage and overdose rates is questionable. One would ordinarily assume that patients suffering from the greatest pain, and thus requiring the highest dosages of opioid, would also be at much higher risk for depression, suicide and substance abuse. Therefore, any attempt to associate overdose rates and dosage statistically would likely be an artefact of a post hoc error in logic. The causes of an overdose are far more likely to be the extent and duration of pain, depression and suicidality, the extent to which the pain is relieved or naiveté about the use of opioids, rather than the milligram dosage consumed.
Previous Section
Footnotes
Competing interests None.
Saturday, May 8, 2010
Response to the FDA Opiods REMS
Response to Docket No. FDA - 2009-N-0143
May 6, 2010
The National Foundation for the Treatment of Pain has responded previously to this REMS proposal . The previous submission provided extensive analysis of the data proposed by FDA in support of the claimed need for REMS activity regarding oxycodone and other opioids, both sustained and immediate release. This analysis clearly established that there is no defensible statistical basis for restricting the already inadequate treatment of pain in America because of the statistically insignificant incidence of overdoses from the abuse of illicitly obtained prescriptive medications.
NFTP urges FDA to revisit this analysis of the data we have previously submitted. It is plainly obvious to any individual trained in statistics and statistical analysis that the occurrence of overdoses and abuse of prescriptive medications, particularly the opioids, has increased over the last few years, as drug abusers have redirected their activities toward prescribed medications in addition to illicitly drugs of abuse. However, simply stated, there is a profound difference between the concept of "occurrence" and that of "incidence".
A recent article by the editor of Science News
http://www.sciencenews.org/view/feature/id/57091/title/Odds_Are%2C_Its_Wrong
brilliantly addresses the short-comings and pitfalls of statistical arguments in support of conclusions, policies and egulation. The burdens upon the health care system of any proposed REMS must be minimized. y objectives and beliefs. It is strongly recommended that FDA consider it carefully.
While the unfortunate and sometimes tragic consequences of misuse of prescribed medications has increased, the incidence of such events is statistically insignificant when calculated against the total number of prescriptions and legitimate ingestions of these drugs is considered. For example, while almost 8,000 overdose deaths in 2009 from the illicit diversion and ingestion of opioids is a tragedy to the families and friends of the individuals involved, compared to the hundreds of millions of doses safely ingested out of medical necessity, these fatalities are not statistically significant. Simply stated, while NFTP recognizes the political pressure directed at the FDA by the sensationalized media focus on overdose deaths, a Draconian REMS response by FDA would be a clear example of throwing the baby out with the bathwater.
Related to this issue, NFTP strongly supports the views of other interested parties who have responded to this docket matter. Specifically: The burden of any proposed REMS upon the health care system must be minimized. Opiophobia is already a cancer upon the body of American medicine. Adding any additional barriers and burdens upon medical practitioners will only further increase the shameful lack of willingness of physicians to accept responsibility for the adequate treatment of pain. There are 40 million chronic pain patients in America, the vast majority of whom suffer needlessly and endlessly from lack of pain medication. The deaths of even 8,000 drug abusers hardly justifies giving physicians an additional incentive to avoid them.
1. Any proposed REMS elements should be proven to reduce the risk of abuse, misuse or diversion. The concept of the "cost/benefit ratio" for these elements must be carefully examined and researched, prior to their imposition upon the health care system.
2. The REMS should not impose a patient registry upon intractable pain patients. They are already demonized, stereotyped, abused, avoided and abandoned by their families, society, the medical community and policy-makers. Requiring them to register will impose burdens, vulnerabilities and opprobrium upon them far beyond their current suffering, which is already a national disgrace. State and national data systems to track schedule II prescriptions are more than adequate to contain diversion and abuse. Pain patients are not sexual offenders and should not be treated as though they are.
3. Existing DEA registration mechanisms should be used to track and confirm prescriber competency. The skillful and competent management of pain should be an absolutely essential component of every physician's medical skills. Doctors who refuse to treat, and who avoid pain patients, should be identified and re-educated as to their professional, moral and ethical responsibilities. Additional burdens and barriers to prescribing will only worsen the already catastrophic unavailability of effective pain treatment.
4. Any proposed REMS must include all classes and types of opioids, so that regulatory forces don't distort the practice of medicine. The vast majority of abuse of opioids, including fatal overdoses, occur from the abuse of hydrocodone and oxycodone products combined with acetaminophen, ibuprofen or aspirin. REMS directed only at sustained release opioids will drive physicians to prescribe precisely the medications that already cause the vast majority of abuse and overdose problems. Again, however, when one contrasts the hundreds of millions of doses of short and sustained acting opioids that are safely and appropriately ingested each year, to the few thousand instances of overdose from illicit use, there is no reasonable basis for any such change in public policy other than a chimerical need generated by tabloid-driven hysteria.
In summary, NFTP supports the position of every pain advocacy organization that:
1. The problems FDA is seeking to solve with a class-wide opioid REMS, as well as obvious potential consequences (such as, fewer prescribers and reduced access to care) need to have clear definitions and baseline measurements to adequately assess the effectiveness of any REMS.
2. The REMS elements should be proven to reduce the defined problems before finalizing them as regulations, including the use of phased-in testing if no such evidence exists.
3. Any opioid REMS should include ALL classes of opioids, not just extended release opioids.
4. The REMS should not include a patient registry.
5. The REMS should include comprehensive, interoperable State Prescription Drug Monitoring Programs and FDA should appeal to Congress and the Administration for expansion of these programs, through greater funding of the NASPER law or other means.
6. Appropriate opioid education, developed by professional associations, should be voluntary for all prescribers of controlled substances until a system can be put in place that can verify education without disrupting the access to these important medicines and without disrupting the delivery of care. Any system should have minimal administrative burdens on both prescribers and dispensers. DEA should utilize its existing registration procedures to track and confirm the completion of such education. Any such system should make it absolutely clear that the effective management of pain is the ethical duty of every physician, and that Opiophobia is a form of pharmacological racism - irrational, unacceptable and contemptible.
PREVIOUS NFTP RESPONSE TO PROPOSED REMS:
The potential harm that is the object of these concerns actually presents an extremely low risk to pain patients who utilize opioids to contain their suffering sufficiently to give them a reasonable quality of life. Even 8,000 opioid deaths in a single year is a minuscule number, compared with the 150 million doses of opioid safely prescribed in the same year. Further, when these deaths are examined objectively, most occurred as a consequence of what doctors call "polypharmacy" - the combining of alcohol, sedatives, illicit stimulants and often many other drugs, with the opioid. These deaths are the consequence of the abuse of drugs - out of ignorance, peer pressure, compulsive behavior and addictive disorders. They are never the result of use as prescribed. Therefore, the supposition that reducing the availability of opioids will effect a reduction in this kind of overdose death is either naive, or a cynical strategy for generating support for a new extension of the "War on Drugs".
Indeed, as with the lessons learned from the Prohibition of alcohol, the consequences are only greater harm. Restricting the legitimate provision of opioids drives patients to illicit sources. Illicit drugs are not only potentially contaminated and of unpredictable potency, but they also support crime and international criminality. Addicts have never had their disease mitigated by the restriction of supply. Criminal suppliers always find means to meet their demands.
Finally, the current proposal, to restrict the prescribing of opioids by imposing more requirements on physician prescribers, is a dreadful folly.
1. The real crisis regarding opioids is the unavailability of medical management of pain - there are almost 4,500 untreated pain patients for every abuser dead of polypharmacy involving an opioid.
2. Physicians are already dysfunctionally opiophobic - imposing further requirements upon them would catastrophically further reduce the number available for the medical management of pain.
3. EVERY physician's training should make them completely competent to treat pain - acute and chronic. Establishing a special category and training requirements for opioid prescribing would defeat this essential goal.
4. Instead, medical schools should be required to adequately train EVERY physician in pain management as a requisite for obtaining a license to prescribe.
5. The mythologies of opiophobia must be eliminated by competent clinical training in pharmacology. Any physician who practices opiophobia is de facto pharmacologically incompetent.
So, in summary, practicing evidence-based medicine unavoidably leads us to the conclusions that:
1. The need for the proposed REMS is unproven and factually unprovable.
2. The imposition of what is proposed would not only be a national folly, but have horrendous negative consequences for both pain patients and the general public.
3. Criminals would be the primary constituency to benefit from the proposals.
4. What is proposed would have no impact, whatever, upon the incidence of accidental overdose deaths involving opioids of substance abusers.
5. The resources wasted on the proposal would be far more wisely invested in the education of ALL physicians, and ALL young people, and in providing medical treatment for the addictive disorders as an alternative to the criminal justice system..
J.S.Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org
May 6, 2010
The National Foundation for the Treatment of Pain has responded previously to this REMS proposal . The previous submission provided extensive analysis of the data proposed by FDA in support of the claimed need for REMS activity regarding oxycodone and other opioids, both sustained and immediate release. This analysis clearly established that there is no defensible statistical basis for restricting the already inadequate treatment of pain in America because of the statistically insignificant incidence of overdoses from the abuse of illicitly obtained prescriptive medications.
NFTP urges FDA to revisit this analysis of the data we have previously submitted. It is plainly obvious to any individual trained in statistics and statistical analysis that the occurrence of overdoses and abuse of prescriptive medications, particularly the opioids, has increased over the last few years, as drug abusers have redirected their activities toward prescribed medications in addition to illicitly drugs of abuse. However, simply stated, there is a profound difference between the concept of "occurrence" and that of "incidence".
A recent article by the editor of Science News
http://www.sciencenews.org/view/feature/id/57091/title/Odds_Are%2C_Its_Wrong
brilliantly addresses the short-comings and pitfalls of statistical arguments in support of conclusions, policies and egulation. The burdens upon the health care system of any proposed REMS must be minimized. y objectives and beliefs. It is strongly recommended that FDA consider it carefully.
While the unfortunate and sometimes tragic consequences of misuse of prescribed medications has increased, the incidence of such events is statistically insignificant when calculated against the total number of prescriptions and legitimate ingestions of these drugs is considered. For example, while almost 8,000 overdose deaths in 2009 from the illicit diversion and ingestion of opioids is a tragedy to the families and friends of the individuals involved, compared to the hundreds of millions of doses safely ingested out of medical necessity, these fatalities are not statistically significant. Simply stated, while NFTP recognizes the political pressure directed at the FDA by the sensationalized media focus on overdose deaths, a Draconian REMS response by FDA would be a clear example of throwing the baby out with the bathwater.
Related to this issue, NFTP strongly supports the views of other interested parties who have responded to this docket matter. Specifically: The burden of any proposed REMS upon the health care system must be minimized. Opiophobia is already a cancer upon the body of American medicine. Adding any additional barriers and burdens upon medical practitioners will only further increase the shameful lack of willingness of physicians to accept responsibility for the adequate treatment of pain. There are 40 million chronic pain patients in America, the vast majority of whom suffer needlessly and endlessly from lack of pain medication. The deaths of even 8,000 drug abusers hardly justifies giving physicians an additional incentive to avoid them.
1. Any proposed REMS elements should be proven to reduce the risk of abuse, misuse or diversion. The concept of the "cost/benefit ratio" for these elements must be carefully examined and researched, prior to their imposition upon the health care system.
2. The REMS should not impose a patient registry upon intractable pain patients. They are already demonized, stereotyped, abused, avoided and abandoned by their families, society, the medical community and policy-makers. Requiring them to register will impose burdens, vulnerabilities and opprobrium upon them far beyond their current suffering, which is already a national disgrace. State and national data systems to track schedule II prescriptions are more than adequate to contain diversion and abuse. Pain patients are not sexual offenders and should not be treated as though they are.
3. Existing DEA registration mechanisms should be used to track and confirm prescriber competency. The skillful and competent management of pain should be an absolutely essential component of every physician's medical skills. Doctors who refuse to treat, and who avoid pain patients, should be identified and re-educated as to their professional, moral and ethical responsibilities. Additional burdens and barriers to prescribing will only worsen the already catastrophic unavailability of effective pain treatment.
4. Any proposed REMS must include all classes and types of opioids, so that regulatory forces don't distort the practice of medicine. The vast majority of abuse of opioids, including fatal overdoses, occur from the abuse of hydrocodone and oxycodone products combined with acetaminophen, ibuprofen or aspirin. REMS directed only at sustained release opioids will drive physicians to prescribe precisely the medications that already cause the vast majority of abuse and overdose problems. Again, however, when one contrasts the hundreds of millions of doses of short and sustained acting opioids that are safely and appropriately ingested each year, to the few thousand instances of overdose from illicit use, there is no reasonable basis for any such change in public policy other than a chimerical need generated by tabloid-driven hysteria.
In summary, NFTP supports the position of every pain advocacy organization that:
1. The problems FDA is seeking to solve with a class-wide opioid REMS, as well as obvious potential consequences (such as, fewer prescribers and reduced access to care) need to have clear definitions and baseline measurements to adequately assess the effectiveness of any REMS.
2. The REMS elements should be proven to reduce the defined problems before finalizing them as regulations, including the use of phased-in testing if no such evidence exists.
3. Any opioid REMS should include ALL classes of opioids, not just extended release opioids.
4. The REMS should not include a patient registry.
5. The REMS should include comprehensive, interoperable State Prescription Drug Monitoring Programs and FDA should appeal to Congress and the Administration for expansion of these programs, through greater funding of the NASPER law or other means.
6. Appropriate opioid education, developed by professional associations, should be voluntary for all prescribers of controlled substances until a system can be put in place that can verify education without disrupting the access to these important medicines and without disrupting the delivery of care. Any system should have minimal administrative burdens on both prescribers and dispensers. DEA should utilize its existing registration procedures to track and confirm the completion of such education. Any such system should make it absolutely clear that the effective management of pain is the ethical duty of every physician, and that Opiophobia is a form of pharmacological racism - irrational, unacceptable and contemptible.
PREVIOUS NFTP RESPONSE TO PROPOSED REMS:
The potential harm that is the object of these concerns actually presents an extremely low risk to pain patients who utilize opioids to contain their suffering sufficiently to give them a reasonable quality of life. Even 8,000 opioid deaths in a single year is a minuscule number, compared with the 150 million doses of opioid safely prescribed in the same year. Further, when these deaths are examined objectively, most occurred as a consequence of what doctors call "polypharmacy" - the combining of alcohol, sedatives, illicit stimulants and often many other drugs, with the opioid. These deaths are the consequence of the abuse of drugs - out of ignorance, peer pressure, compulsive behavior and addictive disorders. They are never the result of use as prescribed. Therefore, the supposition that reducing the availability of opioids will effect a reduction in this kind of overdose death is either naive, or a cynical strategy for generating support for a new extension of the "War on Drugs".
Indeed, as with the lessons learned from the Prohibition of alcohol, the consequences are only greater harm. Restricting the legitimate provision of opioids drives patients to illicit sources. Illicit drugs are not only potentially contaminated and of unpredictable potency, but they also support crime and international criminality. Addicts have never had their disease mitigated by the restriction of supply. Criminal suppliers always find means to meet their demands.
Finally, the current proposal, to restrict the prescribing of opioids by imposing more requirements on physician prescribers, is a dreadful folly.
1. The real crisis regarding opioids is the unavailability of medical management of pain - there are almost 4,500 untreated pain patients for every abuser dead of polypharmacy involving an opioid.
2. Physicians are already dysfunctionally opiophobic - imposing further requirements upon them would catastrophically further reduce the number available for the medical management of pain.
3. EVERY physician's training should make them completely competent to treat pain - acute and chronic. Establishing a special category and training requirements for opioid prescribing would defeat this essential goal.
4. Instead, medical schools should be required to adequately train EVERY physician in pain management as a requisite for obtaining a license to prescribe.
5. The mythologies of opiophobia must be eliminated by competent clinical training in pharmacology. Any physician who practices opiophobia is de facto pharmacologically incompetent.
So, in summary, practicing evidence-based medicine unavoidably leads us to the conclusions that:
1. The need for the proposed REMS is unproven and factually unprovable.
2. The imposition of what is proposed would not only be a national folly, but have horrendous negative consequences for both pain patients and the general public.
3. Criminals would be the primary constituency to benefit from the proposals.
4. What is proposed would have no impact, whatever, upon the incidence of accidental overdose deaths involving opioids of substance abusers.
5. The resources wasted on the proposal would be far more wisely invested in the education of ALL physicians, and ALL young people, and in providing medical treatment for the addictive disorders as an alternative to the criminal justice system..
J.S.Hochman MD
Executive Director
The National Foundation for the Treatment of Pain
www.paincare.org
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